[Federal Register Volume 75, Number 89 (Monday, May 10, 2010)]
[Notices]
[Pages 25869-25870]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11008]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0233]
The National Institutes of Health and the Food and Drug
Administration Joint Leadership Council: Stakeholders Meeting; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting, in conjunction with the National Institutes of Health (NIH),
to solicit comments from interested persons on how the agencies can
more effectively collaborate to advance the translation of biomedical
research discoveries into approved diagnostics and therapies as well as
promote science to enhance the evaluation tools used for regulatory
review. A newly formed NIH-FDA Joint Leadership Council will help
ensure that regulatory considerations form an increasing component of
biomedical research planning, and that the latest science is integrated
into the regulatory review process.
DATES: The public meeting will be held on June 2, 2010, from 8:30 a.m.
to 12:30 p.m. Persons interested in attending the meeting must register
by Wednesday, May 26, 2010, at 5 p.m. e.s.t. (see section III of this
document). Submit written or electronic comments by Wednesday, May 26,
2010, at 5 p.m. e.s.t.
ADDRESSES: The public meeting will be held at FDA, 10903 New Hampshire
Ave., Bldg. 31, rm. 1503C, Silver Spring, MD 20993-0002.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket
number found in brackets at the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, rm. 4283, Silver Spring, MD 20993-0002, 301-796-4769, FAX:
301-847-8617, e-mail: rakesh.raghuwanshi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
With the dramatic breakthroughs occurring in biomedical research
discovery, new public health challenges on the rise, an ever-changing
economic landscape resulting from globalization, and the prospect for
fundamental changes to healthcare delivery in the United States, there
is a pressing need for greater collaboration between FDA and NIH. Both
NIH and FDA have the goals of translating science discoveries into
medical products and therapies, and both NIH and FDA have important
roles and contributions to make towards these efforts. To address these
important areas of common interest, NIH and FDA announced a new
partnership effort that includes, among other initiatives, the
regulatory science program and the NIH-FDA Joint Leadership Council.
The NIH-FDA Joint Leadership Council provides a forum for the
leadership of both agencies to: (1) Work together on strategic planning
at a high level; (2) stimulate an enhanced culture of collaboration
between the agencies at all levels; and (3) further coordinate and
target efforts to promote promising new therapies using the latest
technological advances, such as stem cell biology, biomarkers, and
computational sciences. NIH and FDA plan to work jointly to address the
gap between biomedical research discoveries and new medical products.
They can create new programs to support development of innovative
therapies and promote personalized medicine, utilizing new clinical
trial design strategies and regulatory review processes incorporating
the use of genetic or other biomarkers and information technologies.
These activities will also support postmarketing and/or other
population-based surveys for safety assessments. Overall, there are
many new avenues for NIH and FDA to explore such that we can deliver
safer and more effective treatments faster.
II. Scope of the Meeting
FDA and NIH are interested in receiving comments from the public on
the regulatory considerations that should be an integral part of the
biomedical research program development and scientific tools or
approaches that would enhance the ability to evaluate new medical
products. The comments should focus on ways in which NIH and FDA can
partner to promote interdisciplinary biomedical research through
scientific exchange and new programs designed to advance innovation and
development of new therapies incorporating many of the latest basic
research discoveries. Suggestions about the ways FDA and NIH can work
together to promote an integrated biomedical research agenda including
regulatory review approaches and/or processes on areas of common
interest and mission are being sought. Some areas for which we are
specifically interested in input are the following:
1. What steps should be taken to enhance the translation of
biomedical research discoveries into new and approved preventatives,
diagnostics, therapies, or devices for clinical use?
2. What are the priority scientific issues that currently need to
be addressed (e.g., clinical trial design, endpoint selection and
qualification, bioinformatics needs) in order to inform regulatory
assessments and analyses of new products?
3. How could we enhance the exchange of scientific information
across all sectors in order to better identify and prioritize
scientific areas for emphasis in regulatory research?
4. What mechanisms for the support of regulatory science research
would be most effective and efficient in addressing pressing priority
areas in the translational pipeline?
III. Registration To Attend and/or To Participate in the Meeting
If you wish to attend the public meeting, you must register by e-
mailing Rakesh Raghuwanshi
[[Page 25870]]
(rakesh.raghuwanshi@fda.hhs.gov) by Wednesday, May 26, 2010, at 5 p.m.
e.s.t. When registering, you must provide the following information:
(1) Your name, (2) title, (3) company or organization (if applicable),
(4) mailing address, (5) telephone number, and (6) e-mail address. If
you wish to make a presentation, when you register, indicate the
specific topic or issue to be addressed in your presentation. We will
do our best to accommodate all persons who wish to make a presentation
at the meeting. FDA and NIH encourage persons and groups having similar
interests to consolidate their information for presentation through a
single representative. After reviewing the requests to present, we will
contact each participant prior to the meeting with the amount of time
available and the approximate time the participant's presentation is
scheduled to begin. Presenters must then send the final electronic
copies of their presentations in Microsoft PowerPoint, Microsoft Word,
or Adobe Portable Document to Format (PDF) to Rakesh Raghuwanshi
(rakesh.raghuwanshi@fda.hhs.gov) by Monday, May 31, 2010, at 12 noon
e.s.t.
There is no fee to register for the public meeting and registration
will be on a first-come, first-served basis. Early registration is
recommended because seating is limited. Registration on the day of the
public meeting will be permitted on a space available basis beginning
at 8 a.m.
If you need special accommodations due to a disability, please
inform the meeting contact (see FOR FURTHER INFORMATION CONTACT) by
Wednesday, May 26, 2010, at 5 p.m. e.s.t.
IV. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments. Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
V. Transcripts
Transcripts of the meeting will be available for review
approximately 30 days after the meeting at http://www.regulations.gov
and at the Division of Dockets Management (see ADDRESSES). A transcript
will also be available in either hardcopy or on CD-ROM, after
submission of a Freedom of Information request. Written requests are to
be sent to Division of Freedom of Information (HFI-35), Office of
Management Programs, Food and Drug Administration, 5600 Fishers Lane,
rm. 6-30, Rockville, MD 20857.
Dated: May 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-11008 Filed 5-7-10; 8:45 am]
BILLING CODE 4160-01-S